The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey, 9000
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- having symptoms of SUI according to MESA urinary incontinence questionnaire; age>18 and < 65 years; having the ability of pelvic floor muscle contraction, being free of UI medications for at least 4 weeks before the start of the study; and sufficient literacy to complete required forms and urinary diaries and perform training protocols.
Exclusion Criteria:
- antenatal or postnatal women (up to 3 months after delivery), women with persistent urinary tract infections, impaired mental state, Stage 3 and 4 pelvic organ prolapse (POP), neurological disorders, and who received concurrent or recent physiotherapy intervention (within the last year).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Active Comparator: control
pelvic floor muscle training
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Pelvic floor muscle training consist of fast (2 second) and slow contractions (5-s contraction, 10-s hold, 5-s relaxation, totally 20-s).
One set of exercises includes ten fast and ten slow voluntary PFM contractions (VPFMCs).
During week 1 and 2, participants will be instructed to perform two sets of exercises per day (20 fast and 20 slow contractions per day), which was progressively increased by two sets: four sets per day at week 3 and 4 (40 fast and 40 slow contractions per day); six sets per day at week 5 and 6 (60 fast and 60 slow contractions per day); eight sets per day at week 7 and 8 (80 fast and 80 slow contractions per day); ten sets per day from week 9 to week 12 (100 fast and 100 slow contractions per day).
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Experimental: intervention
vaginal tampon training.
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Pelvic floor muscle training consist of fast (2 second) and slow contractions (5-s contraction, 10-s hold, 5-s relaxation, totally 20-s).
One set of exercises includes ten fast and ten slow voluntary PFM contractions (VPFMCs).
During week 1 and 2, participants will be instructed to perform two sets of exercises per day (20 fast and 20 slow contractions per day), which was progressively increased by two sets: four sets per day at week 3 and 4 (40 fast and 40 slow contractions per day); six sets per day at week 5 and 6 (60 fast and 60 slow contractions per day); eight sets per day at week 7 and 8 (80 fast and 80 slow contractions per day); ten sets per day from week 9 to week 12 (100 fast and 100 slow contractions per day).
Vaginal tampon training will be applied for 5 days a week for 12 weeks.
Exercises with tampons will be performed two days a week by physiotherapist (first author) and three days a week by patients.
One set of tampon exercises consist 15 contractions.
During vaginal tampon training, from week 1 to week 12, patients were instructed to perform two sets of exercises for five days a week (two days by physiotherapist, three days by themselves).
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Global rating of improvement
Time Frame: change from baseline subjective improvement at 12 weeks
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A four-point scale (worse, unchanged, improved, cured) was used to determine the subjective perception of SUI improvement
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change from baseline subjective improvement at 12 weeks
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pelvic floor muscle strength (PFMS)
Time Frame: change from baseline pelvic floor muscle strength at 12 weeks
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A vaginal perineometer (Cardio Design Pty Ltd., Australia) will be used to assess PFME with an arbitrary scale of 0-12.
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change from baseline pelvic floor muscle strength at 12 weeks
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Pelvic floor muscle endurance (PFME)
Time Frame: change from baseline pelvic floor muscle endurance at 12 weeks
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A vaginal perineometer (Cardio Design Pty Ltd., Australia) will be used to assess PFME with an arbitrary scale of 0-12.
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change from baseline pelvic floor muscle endurance at 12 weeks
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Severity of urinary incontinence
Time Frame: change from baseline severity of incontinence at 12 weeks
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The severity of urinary incontinence will be questioned using the Incontinence Severity Index (ISI).
The ISI included two items such as the frequency of urinary incontinence and amount of urinary incontinence.
The total score is calculated by multiplying these items.
The total score of ISI rages from 0 to 12. Higher scores presents severe urinary incontinence.
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change from baseline severity of incontinence at 12 weeks
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Frequency of micturition
Time Frame: change from baseline subjective improvement at 12 weeks
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Participants will complete three 24-h frequency volume charts on 3 nonconsecutive days, and the mean of the 3 days are obtained for analysis
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change from baseline subjective improvement at 12 weeks
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Incontinent episodes
Time Frame: change from baseline incontinent episodes at 12 weeks
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Participants will complete three 24-h frequency volume charts on 3 nonconsecutive days, and the mean of the 3 days are obtained for analysis
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change from baseline incontinent episodes at 12 weeks
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: Türkan Akbayrak, PhD, Hacettepe University
Publications and helpful links
General Publications
- Kashanian M, Ali SS, Nazemi M, Bahasadri S. Evaluation of the effect of pelvic floor muscle training (PFMT or Kegel exercise) and assisted pelvic floor muscle training (APFMT) by a resistance device (Kegelmaster device) on the urinary incontinence in women: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):218-23. doi: 10.1016/j.ejogrb.2011.06.037. Epub 2011 Jul 7.
- Bump RC, Hurt WG, Fantl JA, Wyman JF. Assessment of Kegel pelvic muscle exercise performance after brief verbal instruction. Am J Obstet Gynecol. 1991 Aug;165(2):322-7; discussion 327-9. doi: 10.1016/0002-9378(91)90085-6.
- Hay-Smith EJ, Bo Berghmans LC, Hendriks HJ, de Bie RA, van Waalwijk van Doorn ES. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2001;(1):CD001407. doi: 10.1002/14651858.CD001407.
- Orhan C, Akbayrak T, Ozgul S, Baran E, Uzelpasaci E, Nakip G, Ozgul N, Beksac MS. Effects of vaginal tampon training added to pelvic floor muscle training in women with stress urinary incontinence: randomized controlled trial. Int Urogynecol J. 2019 Feb;30(2):219-229. doi: 10.1007/s00192-018-3585-7. Epub 2018 Mar 13.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- GO 16/506-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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